Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT07028203
Eligibility Criteria:
Inclusion Criteria:
* Healthy male or female subjects over 21 years of age seeking aesthetic improvement of the periorbital area
* Subjects should be able to understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form
* Presence of clearly visible aging signs in the periorbital area (e.g. under-eye bags, periorbital wrinkles) when the face is relaxed as deemed appropriate by the Investigator
* Subjects willing and able to abstain from partaking in any facial treatments other than the study procedure during study participation
* Willingness to comply with study instructions, to return to the clinic for the required visits, and to have photographs of their face taken
Exclusion Criteria:
* Lower eyelid malposition (ectropion, entropion, retraction)
* Blepharitis
* Prior lower eyelid fat removal, skin resection, eyelid surgery or orbital trauma in the past 6 months, prior dermatochalasis of lower eyelids surgical treatment in the past 6 months
* Filler injections in the treatment area and midface region within 3 months prior to the study participation
* Neuromodulator treatment in the periorbital area within 3 months prior to the study participation
* Tattoo(s) and/or permanent make-up in the intended treatment area
* Prior usage within 30 days before the screening or planned usage during the study of retinol, or any medication that can cause dermal hypersensitivity
* Bacterial or viral infection, acute inflammations
* Impaired immune system
* Isotretinoin in the past 12 months
* Skin-related autoimmune diseases
* Radiation therapy and chemotherapy
* Poor healing and unhealed wounds in the treatment area
* Metal implants near treatment area or neutral electrode
* Permanent implant near the area to be treated
* Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body
* Current condition or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles
* History of any type of malignant cancer
* Active collagen diseases
* Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis)
* Pregnancy/nursing or IVF procedure
* History of bleeding coagulopathies, use of anticoagulants
* Any active condition in the treatment area, such as sores, psoriasis, eczema, rash and rosacea
* Any surgical procedure in the treatment area within the last three months or before complete healing
* Poorly controlled endocrine disorders, such as diabetes
* Electroanalgesia without exact diagnosis of pain etiology
* Tuberculosis
* Hepatitis
* Febrile conditions
* Acute neuralgia and neuropathy
* Kidney or liver failure
* Sensitive disorders in the treatment area
* Varicose veins, pronounced edemas
* Skin dermabrasion, skin resurfacing, or deep chemical peeling in the treatment area within 3 months prior to the treatment
* Application in the area of chest, heart, carotid sinus, mouth (i.e. over the lips and in the near proximity) or over the eyes (i.e. over the eyeballs and eyelids)
* Serious psychopathological disorders (such as schizophrenia)
* Neurological disorders (such as multiple cerebrospinal sclerosis, epilepsy)
* Blood vessels and lymphatic vessels inflammation
* Scarring in the treatment area
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT07028203
Study Brief:
Protocol Section:
NCT07028203